RecruitingNot ApplicableNCT07321158

The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools

The Effectiveness of High Versus Low Pulse Duration Neuromuscular Electrical Stimulation (NMES) in Patients With Upper Limb Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools: A Randomized Controlled Trial


Sponsor

University of West Attica

Enrollment

45 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Spasticity is a common symptom that affects more than 50% of patients with upper motor neuron lesions due to damage on pyramidal tract. Despite the current pharmacological and physical therapy rehabilitation methods, previous studies have highlighted the beneficial role of Neuromuscular Electrical Stimulation (NMES) on managing upper limb spasticity. However, due to heterogeneity of application parameters there is a lack of a standardized protocol for spasticity management. The aim of the study will be to examine the effects of high versus low pulse duration neuromuscular electrical stimulation on upper limb spasticity on patients with pyramidal tract-related spasticity. A total of 45 patients will be randomized (1:1:1 ratio) to either high pulse duration NMES (HPD-NMES) or low pulse duration NMES (LPD-NMES) or Control group, receiving the standard of care. Randomization will be performed by an independent investigator, who will allocate participants to one of three groups, using a random number generator, prior to baseline assessment. Each group will receive a 15min-conventional-physiotherapeutic protocol. HPD-NMES and LPD-NMES will receive an additional 30min-NMES protocol of high and low pulse duration, respectively. Pre and post intervention spasticity will be evaluated using Range of Motion (ROM) of the elbow joint through electronic goniometer, Modified Ashworth Scale (MAS) and surface electromyography (EMG). Furthermore, Modified Barthel Index (MBI) and 12-version of World Health Organization Disability Assessment Schedule (WHODAs) will be used for evaluating participants' quality of life. Statistical analysis will aim to highlight the effects of NMES both on the EMG-electrophysiological parameters and on clinical evaluation scales. Additionally, it will seek to determine which of the two NMES pulse durations produced more beneficial results in reducing spasticity levels.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • diagnosis by neurologist with first damage of pyramidal tract with upper limb spasticity
  • absence of cognitive dysfunction
  • normal vital signs

Exclusion Criteria11

  • prior neurological damage to pyramidal tract
  • cognitive decline
  • dermatological damages
  • prior musculoskeletal dysfunction on the upper limb with spasticity
  • presence of metallic residues on the spastic upper limb
  • presence of seizures or psychiatric disorders
  • severe malformation or obesity (BMI \>30kg/m2)
  • history of coronary or other cardiovascular diseases (deep vein thrombosis, pulmonary embolism)
  • presence of systematic inflammatory disease
  • cancer on terminal stages
  • pregnancy.

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Interventions

DEVICEHigh Pulse Duration Neuromuscular Electrical Stimulation Group

30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES) * NMES Application Parameters: * Waveform: rectangular, biphasic. Symmetrical * Pulse Duration:450μsec * Frequency: 100Hz * Intensity: Optical muscle contraction and patients' tolerability * Ramp up: 2sec * Ramp down:2sec * ON/OFFtime: 10sec/30sec (1:3) * Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

DEVICELow Pulse Duration Neuromuscular Electrical Stimulation Group

30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES) * NMES Application Parameters: * Waveform: rectangular, biphasic. Symmetrical * Pulse Duration:100μsec * Frequency: 100Hz * Intensity: Optical muscle contraction and patients' tolerability * Ramp up: 2sec * Ramp down:2sec * ON/OFFtime: 10sec/30sec (1:3) * Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

OTHERUsual Care Group

Conventional physiotherapy training program * Seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocetive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment- Bobath (NDT-Bobath) etc) * Treatment Duration: 15minutes per session, 3 times per week for 6 weeks total.


Locations(1)

Attikon Hospital

Athens, Attica, Greece

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NCT07321158